U.S. patent application number 11/489270 was filed with the patent office on 2008-01-24 for dispensing device.
This patent application is currently assigned to Javelin Pharmaceuticals, Inc.. Invention is credited to Curtis Wright.
Application Number | 20080017658 11/489270 |
Document ID | / |
Family ID | 38663052 |
Filed Date | 2008-01-24 |
United States Patent
Application |
20080017658 |
Kind Code |
A1 |
Wright; Curtis |
January 24, 2008 |
Dispensing device
Abstract
The invention relates to a device for the time-controlled
dispensing of pharmaceutical compositions to a patient. The device
is intended to allow multiple doses of pharmaceutical compositions
to be delivered to a patient over a predetermined or programmable
dosing schedule.
Inventors: |
Wright; Curtis; (Rockport,
MA) |
Correspondence
Address: |
WOLF GREENFIELD & SACKS, P.C.
600 ATLANTIC AVENUE
BOSTON
MA
02210-2206
US
|
Assignee: |
Javelin Pharmaceuticals,
Inc.
Cambridge
MA
|
Family ID: |
38663052 |
Appl. No.: |
11/489270 |
Filed: |
July 19, 2006 |
Current U.S.
Class: |
221/15 |
Current CPC
Class: |
A61J 7/0445 20150501;
A61J 7/0481 20130101 |
Class at
Publication: |
221/15 |
International
Class: |
B65B 59/00 20060101
B65B059/00 |
Claims
1. A device for the controlled release of drug delivery units,
which comprises: a) a magazine for containing a plurality of drug
delivery units; b) a housing containing the magazine, said housing
having an aperture allowing drug delivery units to be removed
therethrough; c) a link by which the magazine may be moved relative
to the housing; and d) a mechanical timing mechanism in
communication with the link, for causing the magazine to be moved
relative to the housing, thereby periodically allowing removal of
individual drug delivery units through the aperture.
2. The device of claim 1, wherein the magazine is configured to
hold 12 drug delivery units.
3. The device of claim 1, wherein the magazine is configured to
hold 24 drug delivery units.
4. The device of claim 1, further including at least one tamper
detection element.
5. The device of claim 4, wherein the tamper detection element
provides an indication of at least one condition selected from the
group comprising: opening the housing, adjusting the timing
mechanism, movement of the magazine by other than the timing
mechanism, and attempts of each.
6. The device of claim 1, wherein the magazine moves relative to
the housing via rotation.
7. The device of claim 6, wherein the link comprises an axle upon
which the magazine may be rotated.
8. The device of claim 7, wherein the timing mechanism communicates
with the axle in a manner such that drug delivery units may be
removed at pre-selected time intervals.
9. The device of claim 1, wherein the combined plurality of drug
delivery units in the magazine comprises a daily drug dose for a
patient.
10. The device of claim 1, wherein each of the drug delivery units
comprises a single unit dispenser for delivering a drug selected
from the group comprising intranasal ketamine, intranasal morphine,
and mixtures thereof.
11. The device of claim 10, wherein each of the drug delivery units
comprises a Pfieffer intranasal applicator.
12. The device of claim 1, wherein the aperture is accessed via a
door.
13. The device of claim 1, further including a patient dosing
interface.
14. The device of claim 13, wherein the patient dosing interface
includes a lock-out to prevent removal of drug delivery units at
time intervals less than a pre-selected minimum interval.
15. The device of claim 1, further including an indicator to alert
a patient that a drug delivery unit is available.
16. The device of claim 15, wherein the indicator is an audible
alarm, a visual indication, or a combination of both.
17. The device of claim 1 wherein the drug delivery units are
intranasal, ingestible, topical or injectable drug delivery
units.
18. A device for the controlled release of drug delivery units,
which comprises: a) a magazine for containing a plurality of drug
delivery units; b) a housing containing the magazine, said housing
having an aperture allowing drug delivery units to be removed
therethrough; c) a link by which the magazine may be moved relative
to the housing; and d) a mechanical timing mechanism in
communication with the link, for causing the magazine to be moved
relative to the housing, the device having a time-based lock-out to
prevent access to the magazine except at pre-selected time
intervals, thereby allowing removal of individual drug delivery
units through the aperture only at pre-selected time intervals.
19-34. (canceled)
35. A system for the controlled delivery of drugs, the system
comprising: a) at least one drug delivery unit; b) a magazine
constructed and arranged to contain a plurality of drug delivery
units, the magazine containing said at least one drug delivery
unit; c) a housing containing the magazine, said housing having an
aperture allowing said at least one drug delivery unit to be
removed therethrough; d) a link by which the magazine may be moved
relative to the housing; and e) a mechanical timing mechanism in
communication with the link, for causing the magazine to be moved
relative to the housing, thereby periodically allowing removal of
individual drug delivery units through the aperture.
36-51. (canceled)
52. A method for providing drug delivery units to a patient at
pre-selected time intervals, the method comprising the steps of: a)
providing a system for the controlled delivery of drugs, the system
comprising: i) at least one drug delivery unit; ii) a magazine
constructed and arranged to contain a plurality of drug delivery
units, the magazine containing said at least one drug delivery
unit; iii) a housing containing the magazine, said housing having
an aperture allowing said at least one drug delivery unit to be
removed therethrough; iv) a link by which the magazine may be moved
relative to the housing; and v) a mechanical timing mechanism in
communication with the link, for causing the magazine to be moved
relative to the housing, thereby periodically allowing removal of
individual drug delivery units through the aperture; b) providing
the timing mechanism with data indicative of the dosing schedule
for the patient; c) activating the timing mechanism to thereby
allow the patient to withdraw drug delivery units from the system
according to the dosing schedule.
53-68. (canceled)
69. A device for the controlled release of drug delivery units,
which comprises: a magazine containing a plurality of drug delivery
units, wherein the magazine is intended to operate with a device
comprising: a) a housing for containing the magazine, said housing
having an aperture allowing drug delivery units to be removed
therethrough; b) a link by which the magazine may be moved relative
to the housing; and c) a mechanical timing mechanism in
communication with the link, for causing the magazine to be moved
relative to the housing, thereby periodically allowing removal of
individual drug delivery units through the aperture.
70-78. (canceled)
Description
FIELD OF THE INVENTION
[0001] The present invention relates to devices used for dispensing
pharmaceutical compositions to patients in a time-controlled
manner.
BACKGROUND
[0002] Dispensing pharmaceutical compositions to patients is often
complicated by the need to limit the delivery to specific dosing
regimens over specific time periods. In the case of many
pharmaceuticals, delivery times must be controlled to provide
adequate and effective dosing over time, while at the same time
preventing inadequate dosing as well as overdosing.
[0003] The problem is particularly acute with drugs that demand
patient compliance to optimize safety, while maximizing efficacy.
Drugs that fall into this class may have strict administration
schedules and stringent dosing amounts as exemplified by such
classes of molecules to include, but not limited to analgesics,
cardiovascular agents, metabolic disorder treatments, and drugs
used to treat certain cancers. Such drugs may be subject to
overdosing as patients often seek medication prior to the
recommended or allowable prescribed dose and schedule, leading to
the possibility of adverse events, abuse or fatality.
[0004] In supervised healthcare settings, i.e., hospitals, nursing
homes, hospices, clinics, and the like, the problem is addressed by
enabling healthcare practitioners to dispense fixed amounts of
medication for patients at prescribed times in a controlled
fashion. In addition, dosing requires the presence of a
practitioner to determine, monitor, and sometimes adjust the dosing
regimen of the required drug or drugs delivered to the patient in
order to optimize efficacy and safety. Such necessary oversight
places a large burden on the healthcare provider, as it requires
personnel and detailed record-keeping for each patient. Likewise,
in less controlled settings, supervision is still required to
ensure adequate treatment and to prevent either under or overdosing
and/or abuse. A relevant example includes the home healthcare
setting, where visiting nurses are often required to be present for
the delivery of individual drug doses to patients.
[0005] Therefore, a need exists for a user-friendly, simple
drug-dispensing device that may contain several doses of a drug,
provide individual doses available to a patient at prescribed time
intervals, and which moderates some degree of protection to the
patient, both by deterring potential over dosage and by making
diversion by a family member or other visitor obvious.
SUMMARY AND OBJECTS OF THE INVENTION
[0006] One object of the present invention is to provide a simple
device for storing and dispensing prescription drugs.
[0007] A further object of the present invention is to provide a
simple device for storing and dispensing drugs which are
administered to a patient via intranasal means.
[0008] A further object of the present invention is to provide a
simple drug dispensing device that would allow a patient to receive
drug doses at prescribed time intervals.
[0009] Another object of the present invention is to provide a drug
dispensing device that is suitable for use in supervised,
semi-supervised, and unsupervised healthcare settings.
[0010] Another object of the present invention is to provide a drug
dispensing device having indicia thereon to indicate tampering or
other attempts to gain unauthorized access to the drugs contained
therein.
[0011] Still another object of the present invention is to provide
a drug dispensing device that can be programmed by a healthcare
practitioner to dispense drugs to a patient at prescribed
intervals.
[0012] Still another object of the present invention is to provide
a drug dispensing device that can be programmed by a healthcare
practitioner to prevent dispensing drugs to a patient at less than
prescribed time intervals.
[0013] Yet another object of the present invention is to provide a
drug dispensing device that would allow patients to self-administer
drugs over a prescribed time period.
[0014] It is another object of the present invention is to provide
a drug dispensing device that would allow patients to
self-administer such drugs as analgesics, cardiovascular drugs,
drugs used to treat metabolic disorders, and drugs used to treat
certain cancers when desired, but no earlier than at prescribed
intervals.
[0015] It is another object of the present invention to provide a
drug dispensing device that can dispense a prescribed drug regimen
to a patient at prescribed time intervals.
[0016] The above and other objects may be achieved by providing a
device for the controlled release of drug delivery units which
comprises a magazine for containing a plurality of drug delivery
units, a housing containing the magazine having an aperture
allowing drug delivery units to be removed through the housing, a
link by which the magazine may be moved relative to the housing,
and a timing mechanism in communication with the link, for causing
the magazine to be moved relative to the housing, thereby
periodically allowing removal of individual drug delivery units
through the aperture at pre-selected intervals. The device may be
configured to allow dispensing of a specified number of drug
delivery units over an extended time period, for example 12 or 24
hours or more, or it may be configured to allow dispensing of
individual drug delivery units as desired by the patient, provided
that the minimum interval between each delivery is of a
pre-specified length. The various timing and delivery issues may be
controlled by a healthcare provider during loading of the device or
at some time thereafter.
[0017] The above objects and summary of the invention will be more
fully set forth in the Figures and detailed description of the
invention below.
DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a schematic depiction of the device of the present
invention.
[0019] FIGS. 2a and 2b are schematic depictions of intranasal drug
delivery units delivered by one embodiment of the present
invention.
[0020] FIGS. 3a and 3b are schematic top and side views of the base
of one embodiment of the present invention.
[0021] FIGS. 4a and 4b are schematic top and side views of the
housing of one embodiment of the present invention.
[0022] FIGS. 5a-5d are schematic top and side views of the magazine
of two embodiments of the present invention.
[0023] FIGS. 6a and 6b are schematic top and side views of the link
of one embodiment of the present invention.
[0024] FIG. 7 is a schematic depiction of the timing mechanism of
one embodiment of the present invention.
DETAILED DESCRIPTION
[0025] The invention relates broadly to a device for the controlled
dispensing of drug delivery units. As used herein, the term "drug
delivery unit" is intended to refer to a unit dose of a
pharmaceutical composition or an applicator for providing a unit
dose of a pharmaceutical composition. Thus, while the term "drug
delivery unit" may refer to a pill, tablet, capsule, caplet, etc.,
(i.e., a unit dose of a pharmaceutical composition) which is
ingested by a patient, the term is also intended to refer to a
device for delivering a unit dose of a pharmaceutical composition
to a patient. Examples herein include, but are not limited to,
intranasal applicators, such as applicators designed to deliver a
single unit or bidose or multiunit dose of a pharmaceutical
composition to a patient. Thus, as will become apparent, the
present device may be used to dispense compositions which are
ingestible as well as devices for delivering compositions which are
administered by means other than ingestion. In one preferred
embodiment, the invention is configured to dispense intranasal
applicators (such as those manufactured by Ing. Erich Pfeiffer
GmbH, Radofzell, Germany; Pfeiffer of America, Princeton, N.J.),
each loaded with a unit dose of intranasal ketamine, intranasal
morphine, or mixtures thereof, either with or without other
constituents. Likewise, the invention may be configured to dispense
more than one drug delivery unit at any given time, or it may be
configured to dispense a drug delivery unit in the form of, for
example, a capsule at one or more time intervals and a drug
delivery unit in the for of, for example, an intranasal applicator
at one or more different time intervals.
[0026] While the device is intended to be used to dispense any of a
wide variety of drug delivery units, it is particularly adapted for
dispensing controlled, scheduled drugs in a manner that prevents or
provides indicia of overdosing. As noted above, the device is
well-suited for the delivery of intranasal applicators, each loaded
with a unit dose of intranasal ketamine, intranasal morphine, or
mixtures thereof, either with or without other constituents;
however, other drug delivery units are contemplated as well. These
include, but are not limited to, the following drugs listed on DEA
Schedules II, III, IV and V:
TABLE-US-00001 SCHEDULE II DEA Substance Number
1-Phenylcyclohexylamine 7460 1-Piperidinocyclohexanecarbonitrile
8603 Alfentanil 9737 Alphaprodine 9010 Amobarbital 2125 Amphetamine
1100 Anileridine 9020 Benzoylecgonine 9180 Bezitramide 9800
Carfentanil 9743 Coca Leaves 9040 Cocaine 9041 Codeine 9050
Dextropropoxyphene, bulk (non-dosage forms) 9273 Dihydrocodeine
9120 Diphenoxylate 9170 Diprenorphine 9058 Ecgonine 9180
Ethylmorphine 9190 Etorphine HCl 9059 Fentanyl 9801 Glutethimide
2550 Hydrocodone 9193 Hydromorphone 9150 Isomethadone 9226
Levo-alphacetylmethadol 9648 Levomethorphan 9210 Levorphanol 9220
Meperidine 9230 Meperidine intermediate-A 9232 Meperidine
intermediate-B 9233 Meperidine intermediate-C 9234 Metazocine 9240
Methadone 9250 Methadone intermediate 9254 Methamphetamine 1105
Methylphenidate 1724 Metopon 9260 Moramide-intermediate 9802
Morphine 9300 Nabilone 7379 Opium extracts 9610 Opium fluid extract
9620 Opium poppy 9650 Opium tincture 9630 Opium, granulated 9640
Opium, powdered 9639 Opium, raw 9600 Oxycodone 9143 Oxymorphone
9652 Pentobarbital 2270 Phenazocine 9715 Phencyclidine 7471
Phenmetrazine 1631 Phenylacetone 8501 Piminodine 9730 Poppy Straw
9650 Poppy Straw Concentrate 9670 Racemethorphan 9732 Racemorphan
9733 Remifentanil 9739 Secobarbital 2315 Sufentanil 9740 Thebaine
9333
TABLE-US-00002 SCHEDULE III DEA Substance Number Amobarbital &
noncontrolled active ingred. 2126 Amobarbital suppository dosage
form 2126 Anabolic steroids 4000 Aprobarbital 2100 Barbituric acid
derivative 2100 Benzphetamine 1228 Boldenone 4000 Buprenorphine
9064 Butabarbital 2100 Butalbital 2100 Chlorhexadol 2510
Chlorotestosterone (same as clostebol) 4000 Chlorphentermine 1645
Clortermine 1647 Clostebol 4000 Codeine & isoquinoline alkaloid
90 mg/du 9803 Codeine combination product 90 mg/du 9804
Dehydrochlormethyltestosterone 4000 Dihydrocodeine combination
product 90 mg/du 9807 Dihydrotestosterone (same as stanolone) 4000
Dronabinol in sesame oil in soft gelatin capsule 7369 Drostanolone
4000 Ethylestrenol 4000 Ethylmorphine combination product 15 mg/du
9808 Fluoxymesterone 4000 Hydrocodone & isoquinoline alkaloid
15 mg/du 9805 Hydrocodone combination product 15 mg/du 9806
Ketamine 7285 Lysergic acid 7300 Lysergic acid amide 7310
Mesterolone 4000 Methandienone (see Methandrostenolone) 4000
Methandranone 4000 Methandriol 4000 Methandrostenolone 4000
Methenolone 4000 Methyltestosterone 4000 Methyprylon 2575
Mibolerone 4000 Morphine combination product/50 mg/100 ml or gm
9810 Nalorphine 9400 Nandrolone 4000 Norethandrolone 4000 Opium
combination product 25 mg/du 9809 Oxandrolone 4000 Oxymesterone
4000 Oxymetholone 4000 Pentobarbital & noncontrolled active
ingred. 2271 Pentobarbital suppository dosage form 2271
Phendimetrazine 1615 Secobarbital & noncontrolled active ingred
2316 Secobarbital suppository dosage form 2316 Stanolone 4000
Stanozolol 4000 Stimulant compounds previously excepted 1405
Sulfondiethylmethane 2600 Sulfonethylmethane 2605 Sulfonmethane
2610 Talbutal 2100 Testolactone 4000 Testosterone 4000 Thiamylal
2100 Thiopental 2100 Tiletamine & Zolazepam Combination Product
7295 Trenbolone 4000 Vinbarbital 2100
TABLE-US-00003 SCHEDULE IV DEA Substance Number Alprazolam 2882
Barbital 2145 Bromazepam 2748 Butorphanol 9720 Camazepam 2749
Cathine 1230 Chloral betaine 2460 Chloral hydrate 2465
Chlordiazepoxide 2744 Clobazam 2751 Clonazepam 2737 Clorazepate
2768 Clotiazepam 2752 Cloxazolam 2753 Delorazepam 2754
Dexfenfluramine 1670 Dextropropoxyphene dosage forms 9278 Diazepam
2765 Dichloralphenazone 2467 Diethylpropion 1610 Difenoxin 1 mg/25
ug AtSO4/du 9167 Estazolam 2756 Ethchlorvynol 2540 Ethinamate 2545
Ethyl loflazepate 2758 Fencamfamin 1760 Fenfluramine 1670
Fenproporex 1575 Fludiazepam 2759 Flunitrazepam 2763 Flurazepam
2767 Halazepam 2762 Haloxazolam 2771 Ketazolam 2772 Loprazolam 2773
Lorazepam 2885 Lormetazepam 2774 Mazindol 1605 Mebutamate 2800
Medazepam 2836 Mefenorex 1580 Meprobamate 2820 Methohexital 2264
Methylphenobarbital (mephobarbital) 2250 Midazolam 2884 Modafinil
1680 Nimetazepam 2837 Nitrazepam 2834 Nordiazepam 2838 Oxazepam
2835 Oxazolam 2839 Paraldehyde 2585 Pemoline 1530 Pentazocine 9709
Petrichloral 2591 Phenobarbital 2285 Phentermine 1640 Pinazepam
2883 Pipradrol 1750 Prazepam 2764 Quazepam 2881 Sibutramine 1675
SPA 1635 Temazepam 2925 Tetrazepam 2886 Triazolam 2887 Zaleplon
2781 Zolpidem 2783
TABLE-US-00004 SCHEDULE V DEA Substance Number Codeine preparations
- 200 mg/100 ml or 100 gm Difenoxin preparations - 0.5 mg/25 ug
AtSO4/du Dihydrocodeine preparations 10 mg/100 ml or 100 gm
Diphenoxylate preparations 2.5 mg/25 ug AtSO4 Ethylmorphine
preparations 100 mg/100 ml or 100 gm Opium preparations - 100
mg/100 ml or gm Pyrovalerone 1485
[0027] Apart from the above-noted intranasal applicators, each
loaded with a unit dose of intranasal ketamine, intranasal
morphine, or mixtures thereof, other preferred drug delivery units
include unit doses of prescription drugs such as digoxin,
.beta.-blockers, .alpha..sub.2-antagonists, thyroid replacement
drugs, drugs to treat specific diseases (Alzheimer's, AIDS,
diabetes, etc.), anticoagulants, vitamins having potentially toxic
overdosages, and any other ingestible, inhalable, injectable or
topical drug that is provided according to a scheduled regimen.
Other representative drugs include, but are not limited to:
betamethasone, budesonide, cortisone, dexamethasone,
hydrocortisone, methyl-predinisolone, prednisolone, triamcinolone,
capecitabine, chlorambucil, cyclophosphamide, etoposide,
hydroxyurea, imatinib, mercaptopurine, methotrexate, buprenorphine,
butorphanol, codeine, hydrocodone, hydromorphone, levorphanol,
meperidine, methadone, morphine, opium, oxycodone, pentazocine,
oxymorphone, anisindione, dicumarol, warfarin, isocarboxazid,
phenelzine, tranylcypromine, amitriptyline, amoxaphine,
clomipramine, desipramine, doxapin, imipramine, nortriptyline,
protriptyline, trimipramine, olanzapine, risperidone, quetiapine,
ziprasidone, aripiprazole, clozapine, chlorpromazine, fluphenazine,
trifluoperazine, perphenazine, thioridazine, haloperidol,
thiothixene, molindone, loxapine, apomorphine, benztropine
mesylate, entacapone, levodopa/carbidopa/entacapone,
carbidopa/levodopa, pergolide, ropinirole Hcl, amantadine Hcl, and
selegiline Hcl.
[0028] Broadly, in one embodiment, the device is intended to be
loaded with multiple doses of one or more drug delivery units and
programmed to allow the drug delivery units to be dispensed at
predetermined time intervals. In another embodiment, the device is
intended to be loaded with multiple doses of one or more drug
delivery units and programmed to allow the drug delivery units to
be dispensed to a patient when desired, provided that a minimum
time interval has passed between dispensing cycles. In another
embodiment, patients requiring a regimen of several different drugs
over an extended time period may use the device to dispense the
particular prescribed multi-drug regimen at specified time
periods.
[0029] One necessary element of the present invention is a
controllable timing mechanism which is in operable communication
with a delivery system within the device. While the timing
mechanism will be discussed in greater detail below, it is noted
that it may be either an electrical or mechanical timing mechanism.
Although both offer desired utility, mechanical timing mechanisms
offer the advantage of employing the device in the absence of an
electrical source.
[0030] For dispensing of drug delivery units over a scheduled time
period, it is contemplated herein that the timing mechanism may be
controlled either by the device manufacturer or at the time it is
loaded with the desired drug delivery units. Thus, in one
non-limiting example, in which the devise is intended to dispense
drug delivery units hourly over a 12 hour time period, the timing
mechanism may be preprogrammed by the manufacturer. In a further
embodiment, the timing mechanism may include a user interface
through which a particular dosing and time period may be input. One
such non-limiting example would allow a healthcare practitioner to
load the device with, for example, 12 doses of intranasal ketamine,
and then program the timing mechanism to allow the devise to
provide one dose every 2 hours.
[0031] Likewise, it is also contemplated that the device may
include an interface through which a patient may self-administer
drugs on an interval-limited basis. In this embodiment, the device
may include a patient dosing interface through which the patient
requests a drug delivery unit to be dispensed. The timing mechanism
may be programmed by either the manufacturer or a healthcare
practitioner to allow drug delivery units to be dispensed freely,
provided a minimum interval has passed between each dispensing.
[0032] In one embodiment, the device may be used to simplify a
complicated dosing regimen required by a patient. For example, many
patients, particularly elderly patients, require doses of several
different drugs one or more times per day. Selecting the particular
drugs required at particular times can often be complicated or
confusing. In one embodiment, the present invention provides a
means by which proper dosing may be simplified. In particular, the
device may be loaded in a manner which allows several drug delivery
units to be dispensed at one time. As one example, consider the
case of a patient requiring drugs A, B, and C every morning, and
drugs B and D every evening. The chambers in the magazine of the
device may be loaded with alternating combinations of drugs A, B
and C and drugs B and D, and the device may be set to dispense the
alternating combinations to the patient at twelve hour
intervals.
[0033] In a preferred embodiment, it is contemplated that the
entire device, loaded with the required drug delivery units, may be
provided to a patient. This configuration is best applied in
situations where the device will be used for short periods, such as
for acute post-surgical pain relief. Upon termination of pain
medication, the device may be cleaned, loaded with drug delivery
units for a different patient, sealed and re-used. Alternatively,
in applications in which the device will be used for longer
periods, a patient may be provided with a version of the device in
which the magazine used to contain drug delivery units is absent.
In this case, a healthcare practitioner, pharmacist, or other
authorized person may provide a magazine loaded with the
appropriate drug delivery units to the patient. Depleted magazines
may be either refilled, or replaced with fully loaded units.
[0034] The device may be best understood from the description below
with reference to the accompanying Figures.
[0035] In one embodiment, shown in FIG. 1, the device 10 comprises
a base 12, a housing 14 having an aperture 16 which provides access
to the interior of the housing, a magazine 18 for containing drug
delivery units and at least one tamper indicia 20. Each of these
elements, as well as other device components (not shown in FIG. 1)
is described in detail below. The device is well-suited for use
with individual (FIG. 2a) and multiple (FIG. 2b) intranasal drug
delivery units, however, it is not intended to be limited in this
manner. Rather, it is contemplated that any of a wide variety of
delivery units, including but not limited to, intranasal
applicators, pills, capsules, caplets, syringes, inhalers, patches,
vials, and the like may be used in connection with the device.
[0036] The base 12 of the device is depicted schematically as a top
view in FIG. 3a and side view in FIG. 3b. In FIGS. 3a and 3b, the
base 12 comprises a substantially circular platform 22 containing a
central aperture 24. A wall 26 extends downward from the platform
22 periphery to define an interior space below the platform. The
interior space communicates with the central aperture 24.
Optionally, a plurality of feet 28 may extend from portions of the
wall 26 to support the device. In some embodiments, it is desirable
to provide the device 10 with tamper indicia 20 which provide
evidence of attempts to open the device by unauthorized
individuals. While such tamper indicia 20 will be described in
greater detail below, in one embodiment, the base 12 may include
one or more flanges 30 extending outwardly from the platform. These
flanges may contain a bore 32 adapted to mate with similar
structures on the housing 14 to provide a means for securing the
housing 14 to the base 12 in a manner which would evidence attempts
to separate these elements and gain unauthorized access to the
device interior.
[0037] The housing 14 of the device is depicted schematically as a
top view in FIG. 4a and side view in FIG. 4b. In FIGS. 4a and 4b,
the housing comprises a substantially circular enclosure having a
top 34 and a wall 36 extending therefrom. As with the base 12, the
housing 14 may include one or more flanges 38 extending outwardly
from the housing. These flanges may contain a bore 40 adapted to
mate with similar structures on the base 12 to provide a means for
securing the housing 14 to the base 12 in a manner which would
evidence attempts to separate these elements and gain unauthorized
access to the device interior. The wall 36 includes an aperture 42
allowing access to the interior of the housing. The aperture 42 may
comprise simply a region on the circumference of the top 34 from
which the wall 36 does not extend, or it may be formed as a
separate opening in the wall. An optional door, not shown, may
cover the aperture to prevent dust and other unwanted substances
from entering the device interior. The door may include a simple
mechanism that allows it to be opened when a drug delivery unit is
available, and closes and optionally locks it when a drug delivery
unit is not available. The aperture 42, with or without the
optional door, must be large enough to allow a drug delivery unit
to be removed from the device when it is positioned within the
housing 14 adjacent to the aperture 42.
[0038] Positioned within the device in the chamber formed between
the base 12 and the housing 14 is a magazine 50, shown in FIGS.
5a-5d. The magazine 50 comprises a hub 52 having a link interface
54 and a plurality of partitions 56 extending therefrom. When
positioned within the device in the chamber formed between the base
12 and the housing 14, the link interface 54 mates with a link
(described below) and a timing mechanism (described below) to allow
the magazine 50 to be rotated within the device. The partitions 56
define storage regions for the drug delivery units and serve to
move the units through the device, toward the aperture 42, as the
magazine 50 is rotated in a controlled manner. The hub 52 may
contain a drug delivery unit aperture 58 in the regions formed
between the partitions to assist in positioning each drug delivery
unit within the device. The number of partitions used depends on
the particular anticipated dosing regimen with which the device
will be used, as well as the particular timing mechanism selected.
For example, if the device is intended to dispense 12 drug delivery
units over a 24 hour period, the device could have 12 partitions
and a 24-hour timing mechanism. As will be apparent from FIGS. 5a
and 5b, a magazine having 12 partitions defines 12 storage regions
between them. Likewise, in another non-limiting embodiment, shown
in FIGS. 5c and 5d, the magazine may include 24 partitions to
define 24 storage regions. Such a device could be used to deliver
24 drug delivery units hourly over the course of a day when used
with a one-day timing mechanism, or 12 drug delivery units daily
over the course of two days when used with a two-day timing
mechanism. Numerous other combinations of timing and dosing
regimens will be apparent to those of ordinary skill in the
art.
[0039] The magazine 50 is rotated within the device using a link 60
shown in FIGS. 6a and 6b. The link 60 comprises, generally, an axle
having a magazine interface 62 and a timing mechanism interface 64.
The magazine interface 62 mates with the link interface 54 on the
magazine 50 to allow the link, when rotated, to rotate the
magazine. The timing mechanism interface mates with a timing
mechanism, described below, which rotates the link and the magazine
in a controlled manner.
[0040] The timing mechanism 70 is depicted schematically in FIG. 7.
It is anticipated that any of a wide variety of timing mechanisms
may be embodied in the present invention. For example, the timing
mechanism may be an electrical timer that is driven by AC current,
or it may be an electrical timer that is driven by battery power.
In one preferred embodiment, however, the timing mechanism is a
mechanical timer. Mechanical timers are preferred because they are
simple, durable, reliable and do hot require a current source to
operate. Thus, the use of a mechanical timer allows the device to
be employed in a wide variety of environments where electrical
timers would offer little or no usefulness. For example, the device
of the present invention is well suited for military applications
where AC current may be unavailable. Likewise, the device is
suitable for civil defense applications where it may be stored for
extended periods of time prior to use. Mechanical timers are
unaffected by such storage, whereas batteries may not be reliable
in such circumstances.
[0041] The timing mechanism 70 is selected such that it provides
the magazine with one complete rotation over a predetermined dosing
period. Thus, a "one-day" timing mechanism is one that provides the
magazine with one complete rotation over a 24 hour period, a
"two-day" timing mechanism is one that provides the magazine with
one complete rotation over a 48 hour period, a "half-day" timing
mechanism is one that provides the magazine with one complete
rotation over a 12 hour period, etc. The timing device includes a
rotating rod that mates with the link via the timing mechanism
interface 64. As such, as the rod on the timing mechanism is
rotated, it rotates the link, which, in turn, rotates the
magazine.
[0042] The timing mechanism 70 may optionally include an audible
and/or visual indicator that provides an indication when a drug
deliver unit is available for withdrawal from the device. The
audible indicia may be, for example, a bell that rings when a dose
is available, and the visual indicia may be, for example, a colored
segment that becomes visible through the aperture 42 when a dose is
available. Thus, in the case of a 12 dose regimen over the course
of one day, an audible indicia would sound every two hours.
[0043] As noted in FIGS. 3a and 3b and FIGS. 4a and 4b, the device
may include tamper indicia. In the embodiments shown, the tamper
indicia 20 comprises flanges on the base and the housing each
having a bore through which a seal may be inserted. In one
preferred embodiment, the seal comprises an electrical tie-wrap
which can be formed into a loop using a one-way ratchet mechanism
thereon. By inserting tie wraps through the flanges on the base and
housing, the base and housing are secured together in a manner that
prevents unauthorized access to the interior of the device unless
the tie wraps are cut.
[0044] The device is not intended to be tamper-proof. Rather, the
device is intended to provide an indication to a healthcare
practitioner that unauthorized access, or attempts at unauthorized
access, to the device interior have occurred. It should be
understood as well, that any of a wide variety of devices may be
used to secure the housing to the base via the flanges. These
include dial locks, keyed locks, scored labels and tapes, etc.
[0045] In one embodiment of the assembled device, a mechanical
timing mechanism is mounted to the underside of the base in a
manner such that rotating rod extends through the center of the
base and mates with the timing mechanism interface on the link. The
magazine, selected for the particular dosing regimen and loaded
with drug delivery units is positioned on the base in a manner such
that it mates with the magazine interface on the link. The housing
is positioned over this assembly and the tamper indicia is employed
to hold the housing to the base. In one preferred embodiment, the
drug delivery units comprise intranasal dispensers of analgesic
medications intended to be dispensed every two hours over the
course of a full day. As such, a one-day timer and a magazine
having 12 partitions is employed.
[0046] The device above could be stored until needed, and then
employed simply by providing it to a patient and activating the
mechanical timing mechanism, such as by winding. The timing
mechanism will begin to rotate the magazine within the device in a
manner such that a patient can withdraw one drug delivery unit from
the aperture in the housing every two hours. Once a drug delivery
unit is removed from the device, another one will not be available
until the magazine has rotated sufficiently to make another drug
delivery unit available. If the patient attempts to accelerate the
dosing by gaining access to the interior of the device, this
attempt will be evident via the tamper indicia. If the dosing is
intended to be continued over the course of a second day, a
healthcare practitioner can open the device, and either reload the
magazine or replace it with a preloaded magazine.
[0047] In other embodiments of the present invention, individuals
may use the device at home to dispense medications according to
their particular needs. Thus, a patient taking multiple medications
over the course of one or more days may load the magazine, or
obtain personalized preloaded magazines, to provide the appropriate
medications at the appropriate times.
[0048] The individual elements of the device may be made of any of
a wide variety of materials. In one preferred embodiment, the base,
housing, link and magazine are fabricated from a cast or
thermoformed polymer. It is anticipated that the device may be
employed in a manner where the elements are reusable, and thus,
durable plastics are preferred. In one embodiment, however, the
base, housing, timing mechanism and link are intended to be made
available as a packaged unit, and the magazine, loaded with the
appropriate drug delivery units is obtained separately. In this
case, the magazine may be returned during the process of refilling,
or it may be discarded. In the latter case, it is preferred that
the magazine be formed of a biodegradable or recyclable
material.
[0049] The device of the present invention offers a simple, durable
alternative to conventional patient controlled analgesia (PCA)
devices. Unlike common PCA systems, a preferred embodiment the
present invention can operate in the absence of electrical power,
while providing periodic doses of analgesics in a manner that is
tamper evident and self-accounting.
[0050] The device lends itself to use in hospitals, semi-supervised
care environments, and independent supervised care environments. In
post operative patients, the device reduces the cost of care as
there is no need for a healthcare practitioner to periodically
administer the dispensed medications. For end-of-life care, the
device can be used to deliver analgesic medications at a greatly
reduced cost and improved safety. For settings where the patient
needs assistance with determining when to take the medications,
i.e., nursing homes, the device reduces the needs for a healthcare
practitioner at each dosing event. Finally, in natural disaster or
military situations, the device provides a durable means of
dispensing medications in environments where electrical power may
be unavailable.
Equivalents
[0051] The present invention is not intended to be limited in scope
by the specific embodiments described herein, each of which is
presented by way of example only. Various modifications of the
invention in addition to those described herein will become
apparent to those skilled in the art from the foregoing description
and the accompanying figures. Such modifications are intended to
fall within the scope of the claims.
* * * * *